Introduction
Malawi has embarked on a ‘test-and-treat’ approach to prevent mother-to-child transmission of HIV (PMTCT), known as ‘Option B+’, offering all HIV-infected pregnant and breastfeeding women lifelong antiretroviral treatment (ART) regardless of CD4-count or clinical stage. We conducted a cross-sectional qualitative study to explore early experiences surrounding ‘Option B+’ for patients and health care workers (HCWs) in Malawi.
Methods
Study participants were purposively selected across six health facilities in three regional health zones in Malawi. Semi-structured interviews were conducted with women enrolled in ‘Option B+’ (N=24) and focus group discussions were conducted with HCWs providing Option B+ services (N=6 groups of 8 HCWs). Data were analysed using a qualitative thematic coding framework.
Results
Patients and HCWs identified the lack of male involvement as a barrier to retention in care, and expressed concerns at the rapidity of the test-and-treat process, which makes it difficult for patients to ‘digest’ a positive diagnosis before starting ART. Fear regarding the breach of privacy and confidentiality were also identified as contributing to loss-to-follow-up of women initated under the Option B+. Disclosure remains a difficult process within families and couples. Lifelong ART was also perceived as an opportunity to plan future pregnancies.
Conclusions
As ‘Option B+’ continues to be rolled out, novel interventions to support and retain women into care must be implemented. These include providing space, time and support to accept a diagnosis before starting ART, engaging partners and families, and addressing the need for peer-support and confidentiality.
In July 2011, Malawi introduced an ambitious public health program known as “Option B+” which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy, regardless of clinical stage or CD4 count. Option B+ is expected to have benefits for HIV-infected women, their HIV-exposed infants, and their HIV-uninfected male sex partners. However, these benefits hinge on early uptake of PMTCT, good adherence, and long-term retention in care. The PMTCT Uptake and REtention (PURE) study is a three-arm cluster randomized controlled trial to evaluate whether clinic- or community-based peer-support will improve care-seeking and retention in care by HIV-infected pregnant and breastfeeding women, their HIV-exposed infants, and their male sex partners, and ultimately improve health outcomes in all three populations. We describe the PURE Malawi Consortium, the initial work conducted to inform the trial and interventions, the trial design, and the analysis plan. We then discuss concerns and expected contributions to Malawi and the region.
Background
In 2011, Malawi launched Option B+, a program of universal ART treatment for pregnant and lactating women to optimize maternal health and prevent pediatric HIV infection. For optimal outcomes, women need to achieve HIVRNA suppression. We report 6 month HIVRNA suppression and HIV drug resistance in the PURE study.
Methods
PURE study was a cluster-randomized controlled trial evaluating three strategies for promoting uptake and retention; Arm 1: Standard of Care, Arm 2: Facility Peer Support and Arm 3: Community Peer support. Pregnant and breastfeeding mothers were enrolled and followed according to Malawi ART guidelines. Dried blood spots for HIVRNA testing were collected at 6 months. Samples with ART failure (HIVRNA ≥1000 copies/ml) had resistance testing. We calculated odds ratios for ART failure using generalized estimating equations with a logit link and binomial distribution.
Results
We enrolled 1269 women across 21 sites in Southern and Central Malawi. Most enrolled while pregnant(86%) and were WHO Stage 1(95%). At 6 months, 950/1269 (75%) were retained; 833/950 (88%) had HIVRNA testing conducted and 699/833(84%) were suppressed. Among those with HIVRNA ≥1000 copies/ml with successful amplification (N=55, 41% of all VL> 1000 copies/ml), confirmed HIV resistance was found in 35% (19/55), primarily to the Non-nucleoside reverse transcriptase inhibitors(NNRTI) class of drugs. ART failure was associated with treatment default but not study arm, age, WHO stage, or breastfeeding status.
Conclusions
Virologic suppression at 6 months was <90% targets, but the observed confirmed resistance rates suggest adherence support should be the primary approach for early failure in Option B+.
Maternal factors comprising of social, obstetric and anthropometric are found to influence LBW. The present study had found association between obstetric risk factors like age of the mother, parity and gravida with LBW. Similar association was also observed between maternal height, and maternal weight with LBW. However, social factors were not found to be associated with LBW. This could probably be due to RUHSA's intervention which requires a further inquiry.
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